Public Bill Committee

[Mr. Jim Hood in the Chair]

(Except clauses 4, 11, 14 and 23, schedule 2 and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners)

Jimmy Hood: Before we begin, I should say that, if hon. Gentlemen wish to remove their jackets, they are welcome to do so.

Clause 24

Register of information

Question proposed, That the clause, as amended, stand part of the Bill.

Evan Harris: I take this opportunity to welcome you to the Chair, Mr. Hood. We have made excellent progress and I am sure that we shall do so today. As I said during the debate on the amendments to the clause, I have a couple of brief questions to ask. What is the basis for the current amount of data that is collected? The main problem that has been raised with me is the regulatory burden of a full amount of information given in the register of information for all treatment cycles, the majority of which do not result in a pregnancy.
We have debated why it is necessary to maintain a register of information in respect of the treatments that produce a pregnancy and a child. There are at least two main reasons. The first is to enable contact to be made in the future, if requested by a child born through in vitro fertilisation, particularly in respect of donor gametes and non-identifying or identifying information about the genetic parent when the person is not the legal or social parent. The second reason is to ensure that the data is accurate on the outcomes of IVF clinics, given the nature of the business and the relatively high stakes involved compared with other businesses, and thus the potential vulnerabilities of the patients, who are the consumers of the business. The clinicians understand those two reasons, but they ask why it is necessary to have identifying information in such great detail about all patients even when a pregnancy does not result or is not known to result. I imagine that reasons will be given for such action, but I just want to deal with them in advance.
It is necessary to retain information in case of adverse effects of some treatment. However, in that sense, it is not different from any other treatment. It is necessary for medical records to include information so that it is possible to track any potential problems caused by drugs. The potential for risks would be the same as that posed by full medical treatment, but for no other full medical treatment is there a central database, especially on treatment that does not result in pregnancy on which a huge amount of information is collected with patients’ names attached. The clinics that have contacted me about such matters understand that it might be necessary to provide information centrally and use patient numbers, but identifying patients would provide an additional burden that they consider unnecessary unless pregnancy results, in which case such a situation should be possible. I have dealt with the second argument for the need to collect the data and information about outcomes so that success rates are recorded. However, that can be done without the need for detailed, identifying information as set out under the Bill.
Will the Minister say whether the Human Fertilisation and Embryology Authority has received the same representations as I have about the extent to which the regulatory burden of the register of information and requirements will be onerous? Does it recognise that there might be scope for reducing the amount of information, particularly identifying information, that is held on a central database for no good reason over and above the reason that such information is available in medical notes on safety and outcome measures, when no child is produced or known to have been produced? If it recognises that that is a regulatory burden, has any consideration been given to how it could be reduced? While that might have been appropriate in 1990, standard IVF and insemination, particularly where, sadly, it does not result in a pregnancy, are now routine medical techniques and interventions.
It is peculiar that for those routine medical interventions, a great amount of information must be submitted to a central database which has not as yet been used for any research purpose. Without having a central database of identified patients, it is still possible to do research where non-licensed treatments—which could be more extensive in terms of drugs and surgery—are not subject to such requirements. It is a valid point, and I would be interested to hear the Minister’s response.

Mark Simmonds: I join the hon. Member for Oxford, West and Abingdon in welcoming you to the Chair, Mr. Hood, and let me say how much I am looking forward to serving under your guidance and chairmanship. I have three quick questions for the Minister on clause 24 stand part that we did not manage to cover in the debate on the amendments.
The first point is about counselling. Under the clause, the donor is informed when a request has been made for information about them. In most circumstances, there will be many years between the donation that leads to the genetic offspring and the genetic offspring asking for information about the donor. It is a minimum of 18 years, but it could be much longer. Clearly, I welcome the stipulations in schedule 4 that relate to counselling for the person requesting the information, but what about counselling for the original donor? Obviously, it should not be compulsory or mandatory, but there may be significant changes of circumstances—the donor’s life may have changed dramatically, they may be in a marriage or another relationship and it could be extremely traumatic to bring such a new piece of information into their life. I wonder why no counselling is offered in the Bill for the original donor.
The second point is about the disparity in ability to request information at different ages. As I understand it, the donor-conceived person is able to request non-identifiable information at 16, but other information is available only at 18. Perhaps the Minister could put on the record the logic behind that particular difference. It may be simply that people are legally allowed to be in sexual relationships at the age of 16, while 18 is the general cut-off point for moving into adulthood.
The third point is about proposed new section 31ZB, which deals with checking whether people in intimate relationships are genetically related. It is about getting the permission of the other party in that intimate relationship. What happens if both parties in that intimate relationship are under the age of 18, and therefore only able to receive non-identifying information, when the point of getting that information is specifically to identify whether the partner in that intimate relationship is related to them?

Dawn Primarolo: Good morning, Mr. Hood; I welcome you to the Chair. I will deal first with the questions raised by the hon. Member for Oxford, West and Abingdon. I wish to make a request to help me focus on answering the points raised. I say now that there is absolutely no criticism implied, bit it is difficult when the hon. Gentleman puts the case and then put the Government’s case as well. He answers his own questions and ends with a series of questions that he has already answered in the course of what he has said. I will repeat them on this occasion as the Government’s position as well, but we need to try to focus.
The hon. Gentleman asked specifically about the disclosure of information regarding patients, particularly where there have been unsuccessful cycles of IVF. He went on to give the answer. As he pointed out, the answer is, first, that the information has to be collected because at the beginning of the cycle it cannot be known that the cycle is going to be unsuccessful—that there will not be a resultant child. Secondly, the information could be relevant to subsequent courses of treatment and follow-up cycles for the individual. Thirdly, the collection of information clearly provides for long-term consideration and research into fertility drugs and comparing the effects on women, whether there is a pregnancy or not. The information provides the basis for further research. Finally, there may be other important areas in the consideration of treatment—that links back to the question of identifying information, particularly follow-up information. Therefore, the hon. Gentleman put the case for why the proposals are as they are, and he answered on behalf of the Government’s position as well.
The hon. Gentleman asked two further questions. The first was about representations that he had received. He asked whether the Government had received the representations that he had received about the collection of information and asked what was our response? Yes, we did receive those representations. It was not a majority view that the requirements were onerous—there were a few of that view. We considered the information powers, because we appreciated the comments. However, we remained of the view that it was important for the HFEA to collect data for all licensed treatments and that we were striking the correct balance between protecting the confidentiality of patients and allowing disclosure under justifiable circumstances. The BMA supported us in that approach. The hon. Gentleman’s second question was specifically geared to how the provision might create regulatory burdens. My response is that the HFEA’s new electronic data interchange system with clinics should certainly help to ease any feelings that the there is an undue burden of collection of information.
In putting all of those points together, the hon. Gentleman clearly justified the system. We considered some of the views put before us and discussed the matter further. We came to the conclusion that we had struck the right balance. We were supported in that by other stakeholders. We believe that the regulatory burden will be considerably alleviated by the system of electronic exchange.
The hon. Member for Boston and Skegness asked a series of questions, particularly about the disparity—which I will deal with first—between the information to which people are given access at 16 and 18. Again, he touched on the answer in his remarks. We have spoken to all of the stakeholders and, of course, the Committee does not come cold to the discussion. We are talking about a consultation of more than a year, with the consultation results published, followed by draft legislation and the pre-scrutiny stage, and then consideration in another place, before the proposals get here. We have had the opportunity for consideration a number of times. The view was that 18 was the suitable age—in terms of other legal requirements and maturity—to give people access to identifying information about donors. This is, of course, significant personal information that could have a dramatic impact. We cannot be sure that the individual knows already that they are the result of a donation of either sperm or egg. We are relying on the parents to have had discussions with their son or daughter. It was agreed that in extreme cases where the individual has not been informed, 18 is the sensible point for access to information.
The hon. Member for Boston and Skegness also asked why we set the age for access to non-identifying information at 16. I am assured that access at that point is sufficient to ensure that within the records there is no family connection. At that point it is not necessary to know the identity; it is enough to be assured. I am not clear whether in extreme circumstances there would need to be a loop back into the information, and the HFEA would need to consider whether or not identifying information was in the best interests of the individual. I will check that matter and come back to the hon. Gentleman. There are two steps. One applies to, for instance, an individual who at age 16, with consent, is going to get married. It also applies where the parents know that their son or daughter is planning to live with or, as the hon. Gentleman said, be sexually active with a partner, and they want to make sure of the information.
Then the hon. Gentleman asked about counselling for the donor. That was covered in previous debates about counselling when the donor becomes involved in the IVF programme. Of course, an individual has to be aware that the request for information could happen rather a long time ahead and their circumstances could be different by then. That is part of the complexity of counselling when an individual is considering being a donor; it must be thorough. It might be the case that the donor would have access to counselling information at the time that the request for identification was made, just in case. That is not an absolute condition, but it would have to come back round the loop. Counselling would be part of their preparation at the very beginning, as they took the decision to be a donor, but would be accessible again at the time when identifying information could be made available. I understand that there is provision for that. These are delicate points.
The hon. Member for Boston and Skegness asked a question about new section 31ZB and the fact that it does not enable the applicant to find out identification. It does, however, provide access to the information to ensure that there is not an issue that would lead to the need to identify the donor. Should, for some reason, the result that came back from the HFEA raise an issue of concern, that would open up the debate automatically, regardless of age, because the individual would need to know why. Imagining all the circumstances, it is difficult to see that there would not be some pressure on the system at that point. The HFEA would have to deal with that. I hope that I have dealt with the points that were raised by both the hon. Member for Boston and Skegness and the hon. Member for Oxford, West and Abingdon. On the question of consent and information, they have tabled amendments to the next clause that specifically focus on those issues and when consent is needed for the passing on of information. Perhaps some of the other points will be picked up again then.

Evan Harris: I am grateful to have the opportunity to respond to the Minister. I was listening carefully to what she said. In my opening remarks, I did not answer my own question or put the Government’s case. I raised two points that I thought that the Minister might use in her response and raised further points on them to save time. I thought that that would be easier than seeking to intervene on the Minister, which might not be her preference, during her response.
In respect of her second point about the need to have this information for follow-up, even for unsuccessful treatment cycles, that follow-up is done by the doctor and the clinic. That is the same with any medical treatment. There are often follow-up treatments in medicine. It is not usual to be required to record all the details, including identifying information, on the central database in order for there to be an appropriate follow-up. Because of the stringent confidentiality requirements, which we are about to discuss, it might be difficult for one doctor to pass on to another doctor information about previous treatments. I am not sure whether the matter will be helped by this form of national database. I do not believe that future doctors would use the resource to check what existing treatments someone has had; they would normally ask the patient. I do not understand why the issue of follow-up is a good reason to hold this information about unsuccessful treatment cycles.
The Minister also argued in respect of long-term research. I said that I did not see how that was different from any other form of medical treatment in which there is a research interest. I said that research can be done through the usual consent arrangements prospectively or even retrospectively, again with the appropriate consents and ethical approval. My understanding is that there has not been any useful research based on all the information on the database by the HFEA. I know that amendments have been tabled to make such research easier in the future, but it did not seem to be a good argument. That was why I raised my points in advance. It was not to answer my own question, but to help move forward the debate by asking whether they could be addressed. The Minister may feel that she has done that, but I do not feel that there has been sufficient justification. However, I understand her point about not knowing whether there is going to be a pregnancy and therefore needing to collect the information in advance. If people from abroad, or in this country, do not opt to go back for a post-natal follow-up, that data set is incomplete. In the end, we rely on patients coming back for follow-up.

Dawn Primarolo: The hon. Gentleman will concede, I hope, that I also made the point that follow-up was much wider than on the individual patient’s cycles. There is also follow-up about the impact of drugs and incidents of cancer 20 years on. It is about access to information from longer term studies and to understand why one cycle was not unsuccessful and another one was. That may be something that needs to be studied over time. The information was necessary for that type of follow-up as well.

Evan Harris: I understand that justification. As I said earlier, I would argue that it is not necessary to have a national database to do that. We do not have a national database in any other form of medicine, but prospective, case-controlled, and retrospective epidemiological trials are done. Also, no useful data have been gathered from this database in the nearly 20 years that it has been going. I accept, however, that the Bill changes provisions to allow more research. I guess we will know in the future whether that is possible, not only prospectively for new patients, but for all the patients that have been treated.
I understand what the Minister is saying about motives. I am not arguing that this is some form of malevolent intervention. I happen to be of the view—I accept what she says about the consultation and that this is not a majority view—that the benefits of this type of central database for the treatment of donor cells from pregnancy are not worth the regulatory burden. However, I was pleased to hear what she said about the fact that the data collection and entry may be made easier due to technological advances. I think that we all have our fingers crossed on that, given the possibility of these things going wrong. I think that I have made my case, and the Minister has put the Government’s case, and on that basis, I shall finish.

Question put and agreed to.

Clause 24, as amended, ordered to stand part of the Bill.

Clause 25

Restrictions on disclosure of information

Mark Simmonds: I beg to move amendment No. 38, in clause 25, page 26, line 4, at end insert—
‘(za) the disclosure is made—
(i) on clinical grounds, as part of the patient’s medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality, or
(ii) in order to ensure the safety of medical treatment which the patient is to receive outside of licensed premises.’.

Jimmy Hood: With this it will be convenient to discuss the following: Government amendments Nos. 45 and 46.
Amendment No. 150, in clause 25, page 27, line 27, at end insert—
‘(v) the disclosure is made in order to ensure the safety of medical treatment which the patient is to receive outside of licensed premises.’.
Amendment No. 151, in clause 25, page 27, line 27, at end insert—
‘(v) the disclosure is made, on clinical grounds, as part of the patient’s medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality.’.
Government amendments Nos. 47 to 54.
Amendment No. 37, in clause 25, page 28, leave out line 46 to line 8 on page 29.

Mark Simmonds: Clause 25 relates to the sharing of information—between and with whom—the restrictions on disclosure, and the exceptions to those restrictions. I shall speak specifically to amendment No. 38.
In proposed new section 33C to the 1990 Act, the Bill provides for consultation and regulations to be made to allow the disclosure of identifying information without consent for the purposes of medical or other research that is
“necessary or expedient in the public interest or in the interests of improving patient care”.
However, as the Minister and many members of the Committee will be aware, this was debated at some length in the House of Lords. Members of the Lords believed that the confidentiality provisions of the Bill were too tight, thus preventing sufficient research on children born by IVF. In situations in which women conceive through IVF, there is no procedure for the woman’s obstetrician to be told about the method of conception. Clearly, this must be looked at in the context of patient confidentiality. Obviously, if a woman does not want that information to be passed on, her privacy should be protected.
However, there are cases in which sharing such information would be beneficial, and there seems to be a presumption against that information flow, although perhaps the presumption should be in favour of it, even though I do not think that it is relevant that obstetricians need to know who the donor was, or whether it was the partner’s sperm or a donor sperm that fertilised the egg. Clearly, with IVF, women undergo treatment and complex procedures that change the body. Such a thing would, in some circumstances, enhance patient care in the context of strict confidentiality, which does not apply to other sensitive or personal conditions, such as considerations of mental health. The amendment would allow for the sharing of information between medical practitioners, which could improve patient care, in the context of confidentiality. The woman’s privacy would be respected, and consent for that information to be passed on could be withdrawn, if she wished.
Amendment No. 37 would remove the regulation-making power in proposed new section 33B of the 1990 Act. My understanding is that the power enables future additional exceptions to be made on who can request information, who must be informed, and with whom it can be shared. However, if consent is the cornerstone of the Bill, such issues should be debated and put on the face of primary legislation. Members of the Committee will see a very comprehensive list of exemptions on the main thrust of the clause in paragraphs (a) to (u) of proposed new section 33A(2). The matter has obviously been thought through very carefully, but will Minister put on record why she feels that it might be necessary to amend the list, given that it has clearly been thought through in great detail? Can she give the Committee an example of an amendment that might occur in future, although I understand that it might be difficult to find an additional category that is not covered in paragraphs (a) to (u)?
My final point about the clause concerns proposed new section 33A(3)(a), which details the interrelationship between the Bill and the Congenital Disabilities (Civil Liability) Act 1976? Will the Minister explain how the measures work together?
It would be helpful if the Minister could clarify whether the Government amendments are all tidying-up provisions, or whether they would actually change the meaning of the clause. They seem to remove certain provisions, but that could just be tidying-up drafting.

Evan Harris: I tabled a couple of the amendments in the group, but it might be best to hear the Minister’s description of the effects of the Government amendments. They are better drafted than those in my name and, if I may say so, those tabled by the hon. Member for Boston and Skegness. The right hon. Lady’s amendments are comprehensive and complex, and if she is willing to accept questions after she has explained them, that might speed things along.
Amendment No. 151 states that an exception would be made for disclosure on clinical grounds
“as part of the patient’s medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality.”
Those of us who want the rules on confidentiality to be loosened are not talking about a free-for-all. We just want to bring the provisions more, albeit not totally, in line with standard medical care rules under which medical notes are confidential. There are significant professional and, indeed, possibly criminal consequences from a breach of medical confidentiality, which is something that I feel strongly about. I have argued that the same procedure should apply to politicians and their children in respect of vaccinations, given that many in the media think that that should be a free-for-all, although I disagree.
Nevertheless, several clinicians have raised a problem with me. I shall not repeat what Lord Patel and Lord Winston said in the other place because that can be read, but scientists from Newcastle have explained that when a treatment is provided in a separate tertiary clinic, there is a clear distinction between the initial investigation of the problem and the subsequent provision of treatment. In a tertiary NHS referral centre, it is likely that the initial investigations and counselling will be carried out in a general infertility clinic. That might also occur a long time from the possible treatment. For instance, an unmarried 18-year-old with a severe pelvic infection will be counselled about the potential impact on fertility and the need to consider IVF. Such records—I guess because this is a carried out in a licensed centre by a licensed person—are currently included in law under strict confidentiality regulations because they refer to IVF, and that is inappropriate.
There are two ways in which to tackle the problem. We could argue that only limited information should be included in the provisions and that they should be loosened to enable communication between doctors in the best interests of the patients in good faith. Doctors should always be answerable in respect of complaints to medical regulators and the professional regulator, the General Medical Council.
The Government have heard such concerns in the House of Lords on several occasions and I note that their amendments represent a response to that. I look forward to hearing the right hon. Lady explain their effect in detail. I hope that the clinicians who have contacted me will be satisfied by what she says, as well as the potential of the regulation-making power. I share the view of any Opposition parliamentarian that wide-ranging, regulation-making powers are questionable, but I feel more comfortable with the inclusion of the provision, given that I do not think that this debate has ended.
IVF still has a cachet, which makes it sensitive, but as its special status becomes less special, and as it becomes more routine, for many patients—it will always be their decision—it might well become appropriate to change the provisions to ensure that we keep up to date with what is practical and appropriate, rather than stick to what was felt to be appropriate in 1990.

Ian Gibson: I wonder, Mr. Hood, whether I could have your view on an issue about the running of this Committee that is beginning to bother me. Several documents are being floated by people who have tabled amendments. During my time in Parliament, I have sat on several such Committees, and when documents are received from experts, it is important that every Committee member sees them so that we can come to a balanced judgment. Could you rule, Mr. Hood, that if people read from documents from eminent professionals, they be made available to the whole Committee? I say that because, advisably, I challenged a document before, and within an hour, I was being challenged by those who put the document in. My answer to them was, “Why didn’t you send it to all of us? How do I know whether what you are saying is true? Give us the evidence so that we can see.” I think that we are getting restrictive readings from different documents and that the Committee is hearing only half the story. We all feel passionately about this issue and want to get seriously involved.

Jimmy Hood: I thank the hon. Gentleman for his point, but that is not a matter for the Chair. If Members receive information from other sources, it is for them to deal with that as they see fit. If evidence was given to the Committee per se, all members of the Committee would have that information, so that would not be a matter for the Chair.

Ian Gibson: Perhaps the organisations or individuals that send in such information are not aware of Committee procedure. By floating it to one Committee member, they restrict other’s involvement in the debate. When something is put forward, perhaps it should be presented by the individual to the Clerks so that they can judge whether it should be distributed.

Jimmy Hood: Again, the hon. Gentleman makes his point, but I reiterate that that a matter for not the Chair, but those supplying the information to Members and, indeed, the Members themselves.

Dawn Primarolo: The HFEA is required to collect details of licensed treatments for its register of information, which contains identifying information about everyone who has received treatment, including IVF or donor insemination. The 1990 Act prohibits the disclosure of such information by either the HFEA or a licensed practitioner, and that is subject to a criminal offence, as the hon. Member for Oxford, West and Abingdon reminded the Committee. The Bill provides for exceptions to be made to that provision, so we have moved from the requirements of the 1990 Act to the exceptions, some of which we have dealt with this morning. Such exceptions are when a person identified in the information to be released has consented to its release, with the exception, of course, of donor information—we covered this in the previous clause—which is protected to a particular age; when the information would not identify any individual; or in an emergency, when a woman who has received treatment or services is in imminent danger that makes it necessary for information to be released. The list of exceptions consolidates those already permitted under the 1990 Act, as well as introducing some new ones. Furthermore, as the hon. Member for Boston and Skegness mentioned, the Bill contains a regulatory power that enables additional exceptions to be made.
When the hon. Member for Boston and Skegness referred to amendment No. 37, he asked me specifically why we need the regulatory measure. He referred to paragraphs (a) to (u) of proposed new section 33A(2). To be frank, the answer is that every exception that we can think of is already there, although we cannot think into the future in terms of future-proofing. The regulation-making power was in the 1990 Act. Measures would be subject to the affirmative procedure and the power would be a method of future-proofing the Bill, just in case. The hon. Gentleman is right to say that we made every attempt to put everything in the Bill, but we still believe that this measure is necessary in case—as has happened in the past—we need further exemptions. The regulations would not change the principles within which the exemptions work. He asked whether I could name any; I am afraid that I cannot because we think that we have been quite thorough.
I shall deal with amendments Nos. 38, 150 and 151 and respond to the questions asked by both hon. Gentlemen before moving on to the Government amendments. The amendments would provide additional exceptions for the disclosure of information. Specifically, they relate to the situation if the disclosure is made on clinical grounds as part of the patient’s medical care to a practitioner who is bound by the ordinary duty of patient confidentiality, or if it is necessary to ensure the safety of medical treatment that the patient is to receive outside licensed premises. Again, the hon. Member for Oxford, West and Abingdon drew comparisons with what happens elsewhere in medicine with regard to the exchange of information.
The Government’s view is that consent on disclosure should always be obtained when possible, and that doing so need not necessarily be burdensome. We appreciate that there are occasions when, during the course of treatment, it would be necessary for clinicians to share information with other health professionals. However, because of the consent arrangements in the Bill—I will go on to make further points—we feel that it is more appropriate to provide for the obtaining of general consent from the patient for that purpose at the beginning of treatment. That would enable clinicians to be confident that they were not acting outside the patient’s wishes, while also allowing them to share appropriate information regarding the treatment of the patient.
There are circumstances in which patients would perhaps want to limit the people who could be told about their treatment—perhaps they would not want such information to go to a GP who is a relative or a friend. By consenting at the beginning of treatment, the extent of information sharing could be limited accordingly. Again, that echoes back to a theme that we have discussed in previous clauses about the importance of clear explanation to the patient and clear adherence to consent.
Even after amendment, the provision would not provide scope for clinicians to disclose confidential patient information without the patient’s consent. I am not referring to drafting; I will reference other requirements. I should say something to the hon. Member for Oxford, West and Abingdon as a caveat because I have been a Member of the House for 21 years—quite a long time in opposition, although not recently, thank goodness. It is hard to draft amendments because parliamentary counsel are highly skilled. His amendments are about making progress on the principle, and I understand entirely what he wants to do.
The amendments would not provide for that because before information was disclosed to the health care professionals involved in a person’s treatment, the doctor would still need to consider whether disclosure was compatible with the Data Protection Act 1998, common law and any other relevant law where consent is generally required. Therefore, requiring the consent right at the beginning, and allowing that general disclosure, is in our view much more secure for the clinicians as well. They would have to satisfy themselves in all those other areas that they were disclosing information in the correct way. It is the Government’s view that the Bill strikes the right balance in respect of requiring consent to be obtained before identifying information is disclosed, even when that is to other health care professionals, with the exception of emergency situations. Consent to such disclosure in the course of treatment can be obtained, as I said, prior to the initiation of treatment, when the patient is consenting to that treatment.
The amendments that would introduce an exception to the disclosure are, in the Government’s view, inappropriate. The disclosure of identifying information without consent should be permitted only where there is good justification. There was a lot of discussion about that between the Government and stakeholders. The British Medical Association supported the Bill’s position. Obtaining consent for disclosure to health care professionals is possible. Therefore, the exception proposed by the amendments is not justified.
The hon. Member for Oxford, West and Abingdon made a point about the problems of disparity between different medical professions and that we are setting a higher level. I hope that I have dealt with that point, because a general consent at the beginning gives greater certainty and clarity to clinicians than having to satisfy themselves subsequently about data protection, common law and other law relating to confidential information, which is what the amendments would require.
The hon. Member for Boston and Skegness asked about the Congenital Disabilities (Civil Liability) Act 1976. That did not trip off my tongue—I was prompted on the exact date, I hasten to add. The 1990 Act extended the reach of that legislation to cover infertility treatments. Basically, the Bill does not alter that position. The 1976 legislation was carried over to the 1990 Act, which made the cross-reference and put infertility in, but the Bill, as it amends the 1990 Act, is silent on that, because it does not alter the positions. I hope that that deals with his point.
On the Government amendments, I suppose the quick response, although I might have to give a little more detail, is yes, they mostly tidy up the consent exceptions, following discussion in another place. The changes are tidying-up measures. However, there is one instance in which we need to be absolutely clear with regard to the interaction of the exceptions. We have to ensure that we do not inadvertently open up the consent to disclosure of non-identifying information or cause some difficulties in that regard. We are managing two types of information—the identifying and non-identifying—and under what basis it can be disclosed.
We recognise that it is very important that the 1990 Act and the Bill strike the right balance between safeguarding the confidential information of patients, their partner, donors and children held by the HFEA and clinics while, at the same time, allowing information to be disclosed by the HFEA and clinics in circumstances that warrant it. However, the 1990 Act is not always as conducive as it could be in that regard. For example, it prohibits the HFEA from disclosing identifying information about patients, even in cases in which the patient consents to such disclosure. That is one issue that needs to be addressed.
I will go through the Government amendments very quickly and return to them if Members have further questions. Amendment No. 45 amends and simplifies the wording in new section 33A(2)(g) to (j) and clarifies it to strike the important balance on consent, including identifying information as long as individuals have given their consent.
Amendment No. 46 is consequential to the new wording in proposed new section 33A about the disclosure of information, and replaces wording removed by amendment No. 50. It clarifies that the HFEA can disclose identifying information from its register to avoid imminent danger to a person’s health.
Amendment No. 47 removes wording from proposed new section 33A about consent to disclosure when treatment services are provided to two people together and both are identifiable. It recognises the provisions in proposed new section 33AB whereby the consent of each individual identified must be obtained.
Amendment No. 48 removes wording that is consequential and replaces it with wording that will be introduced by amendment No. 54. Amendment No. 49 clarifies that the disclosure of information for the purpose of investigating an offence or suspected offence, or in connection with legal proceedings, does not apply to identifying donor information.
Amendment No. 50 removes wording from new section 33A consequential to the replacement wording that is introduced by amendment No. 46. Amendment No. 51 reflects the fact that the Bill introduces provisions for fatherhood agreements for unmarried couples in which donor sperm is used. Amendment No. 52 is consequential on amendment No. 45. Amendment No. 53 defines what the term “identifying donor information” means with regard to new section 33A(2), which is a consequence of amendment No. 45. Amendment No. 54 applies in conjunction with amendment No. 45.
Therefore, without going into any detail, I am trying to indicate to the hon. Member for Boston and Skegness that we are cross-referencing and making it absolutely clear that the exemptions fit together and do not breach any of the principles. Overall, the Government amendments provide clarification rather than a change of policy by continuing to strike the balance between disclosure of identifying information, particularly that which might be helpful for follow-up research into the health of patients and their children, and ensuring that consent is properly and rightly obtained.
If I have not covered any of the points, Mr. Hood, I would be happy to catch your eye and return to them.

Evan Harris: I am grateful to the Minister for her exposition on the amendments, which I followed on a track changes document—I think that that is the only way to do it. First, in response to a point made by the hon. Member for Norwich, North, I am a little confused. I had a meeting with Alison Murdoch last night, who is a clinician in Newcastle. I am sure that he would have been entitled to attend had I known that he was around and interested.

Ian Gibson: Sorry.

Evan Harris: I did not think that it was illegitimate to meet a clinician—

Ian Gibson: What a cheek!

Evan Harris: And to ask her to e-mail me—[Interruption.]

Jimmy Hood: Order.

Evan Harris: I did not think that it was unreasonable to meet someone and ask them to e-mail me a couple of points because the meeting was coming to an end, and then to raise them in Committee. That is entirely appropriate. In respect of the hon. Gentleman’s point earlier, I checked with Newcastle about the mitochondrial DNA and I checked my e-mail. I understand that that was sent to all members of the Committee. I merely quoted from a document sent to all members of the Committee about the research on mitochondria and IV-derived gametes.

Ian Gibson: That may be so, but in my conversation with them I made it clear that I had not seen that document. They may have sent it, and these things happen now and again. The hon. Gentleman is in a difficult position if it is seen that he may be a lobbyist, rather than a full member of the Committee. I will be watching carefully throughout our proceedings to see whether the individual views of scientists or others are available to all hon. Member, in terms of the whole context of what they have given to him.

Evan Harris: I object to that. If the hon. Gentleman used the term lobbyist as a smear, I object to it, and I object to the assertion that when I and, for that matter, Lord Patel and Lord Turnberg meet any scientist to express concerns about the Bill, we are somehow not doing our job. It is reasonable to do that and we have been diverted in a peculiar way, Mr. Hood. I am happy to hand the hon. Gentleman a copy of the e-mail that was sent to me by Alison Murdoch last night.

Jimmy Hood: Order. I am sure that the hon. Gentleman will get back to the debate.

Evan Harris: I am keen to do so, but I thought it was right to defend the normal activities of Opposition Members. For 10 years I have been meeting people who are concerned about legislation, and I will continue to do so despite the hon. Gentleman’s admonitions.
I want to make two points on the Government’s provisions. Am I correct in understanding that amendment No. 45 does two things, which are brought together in one amendment because proposed new (h) follows on from proposed new paragraph (g)? New paragraph (g) is an important amendment because it makes it clear that the disclosure that would not be permitted is where any individual can be identified from the information, rather than a disclosure whereby no individual to whom the information relates could be identified. That is a separate and helpful amendment, and proposed new paragraph (h) is much more in keeping with the rest of the amendments. They are simply brought together by a good fortune of drafting, that (h) follows (g).
I understand the Minister’s specific point about getting general consent at the beginning. I think that the problem is merely one of interpretation by the HFEA, and what she said will be helpful. In normal clinical practice, information is not divulged without consent; it is divulged with implied consent. When people see a GP they do not have to sign anything to say, “You have my permission to send the information on to a consultant”, because when someone seeks a referral from a GP, it is implied that that information will be transmitted. When the medical or surgical team want to write to GPs to explain that someone is in hospital and has received treatment, that is not done without consent, because it is implied.

Dawn Primarolo: I hope that the hon. Gentleman forgives me, but I forgot to cover that point. I absolutely accept what he says about data protection and general confidentiality, but I remind him that the EU tissues and cell directive sets standards of safety and quality for human tissue intended for human application, which includes areas that we are discussing, and goes further than the Data Protection Act. When I alluded to other legislation that would impinge on confidentiality, I had not meant to be more specific than that. It explains why there is a higher hurdle.

Evan Harris: The Minister has no need to apologise, because I assumed that that was what she meant, and I was going to raise that in my points at the beginning. I thought, given what she had said previously, that I would not raise it in advance. I have a question about it, so it is useful that she has raised it.
Coming back to what I was saying, there is implied consent; treatment is not done without consent. Because of the nature of this treatment, and because of the complication of identifying donor information, there needs to be a process. Otherwise relying on implied consent can lead people to fall into traps of not knowing where the division goes. I understand the reason why there is a need for an explicit or written consent. Consent is a process, and written consent is a sign that there has been a process and it is useful. However, there is a problem with interpretation by the HFEA, because clinicians tell me—I believe that this is on the record in the House of Lords debates as well—that they are required, or feel that they are required, by the HFEA, whether in their code of practice, in their inspection system or by some other means, to get a consent form filled in for every visit, every procedure and every test, even when the general consent form has been filled in at the beginning.
There may be scope here not for legislation, but for it to be made clear to the authority, which may feel that it is doing its job and playing safe, that the requirements of the tissues and cells directive, 2004/23 EC, particularly article 14, can be met by a written general consent at the beginning, and that specific consent is unnecessary as long as patients are made aware that they can at any point change the terms of that consent. That should be straightforward to do, and specific requests can be made for certain information not to be provided. I think that requiring a form each time is unnecessary.
I am hoping that the Minister can assure me that the extra requirements created by the directive would not prevent a general consent at the beginning as long as the patient knows that.

Dawn Primarolo: I am happy to confirm that to the hon. Gentleman. When we were discussing consent at the beginning of our proceedings, we noted that discussions are taking place between the Department and the HFEA, and the HFEA is considering the whole question of consent, the exceptions, and how it is provided. That point might have been raised by the hon. Gentleman. Some of the things that he is saying now would need to be clarified within that discussion. The HFEA would need to take forward those discussions and the support and advice given to clinics.

Evan Harris: That is good news indeed. The Government amendments are an improvement on the existing situation. Using the Minister’s words today—I hope that I have got this right—a general, specific consent at the beginning does not have to be augmented, although it can be resiled from at any point by a patient; they must have the right to change their mind in respect of future disclosures or for new treatments.

Dawn Primarolo: Just to put a qualification in there: of course, that should be within the limitations of the 1990 Act. It is about identifying and non-identifying information about the donor. For example, the identifying information cannot be made available until the child reaches 18; that cannot be the case, and nobody can vary that.

Evan Harris: I completely accept that, and I have had no representations from clinicians questioning the need for such clear separation. They understood that part of being licensed was to understand the sensitivity of that. I welcome the fact that there are ongoing discussions and note that the Government amendments are an improvement. It should be possible to reduce the pressure. The criminal offence worries clinicians, and perhaps they are also playing safe. If the HFEA could make it clear that if they fulfil certain requirements—particularly for patients who give the general consent at the beginning that is not retracted at some point—it should be reasonable.
The only other point to bear in mind is that there is a continuing concern about the differentiation between licensed and non-licensed individuals, licensed and non-licensed treatments, licensed clinics and non-licensed premises. Some of that is inevitable. We cannot have a licence and say that there should not be a difference. The fact that one has to have a licence is because there is a difference, and that creates a difference. The Minister should have a discussion with the HFEA—I emphasise that for the columns of Hansard—about making sure that there is not what seems to be an unfair burden on someone doing normal work who happens to be licensed, or on someone doing work that could take place in an unlicensed place, but who happens to have a licence because they do other work. If it can be shown that they are not unfairly at risk, or facing unfair or unreasonable burdens, people will welcome the progress made, both in the legislation and in our debates.

Mark Simmonds: I thank the Minister for her response to my amendments and for her explanation of the Government amendments.
I accept what the Minister says about amendment No. 37. The list is clearly comprehensive and well thought through. It is correct that if there are to be regulations, or there is a necessity for them, they are subject to the affirmative procedure so that they have to be discussed in Parliament. Everyone on the Committee wants to see the Bill, when it becomes an Act, to last effectively at least as long as its predecessor, the 1990 Act. That is the whole purpose, so regulations can keep up to date with scientific advances as the years go by.
On amendment No. 38, again I thank the Minister. I understand what she says. It is right that there is general consent at the beginning of treatment, within the limitations of the Act, but she seemed to suggest that there was an ability for conditional consent—for information to be passed on. Her example was if the GP might be a family member. Is the Minister saying that exclusions can be specified on the consent form about whom is not able to receive that information, or, as I suspected originally, will there be generic consent?
On the implied consent argument and the exchange that has just taken place between the Minister and the hon. Member for Oxford, West and Abingdon, it is quite right that there is a higher hurdle when we are talking about such issues, as well as about human tissues. I am pleased that there are ongoing discussions with the HFEA and licensed premises, because I am concerned, like the hon. Member for Oxford, West and Abingdon, about the potential to put unreasonable bureaucratic burdens on licensed premises. I hope that those ongoing discussions will facilitate such a situation not occurring.
With regard to the Government amendments, I have one question for the Minister relating to amendment No. 54, which I am not clear about. Proposed new subsection (3) of that amendment reads:
“Consent in respect of a person who has not attained the age of 18 years”—
referred to in the amendment as “C”—
“may be given...by C, in a case where C is competent to deal with the issue of consent”.
If I read that correctly, that implies that someone below the age of 18 could give consent. How young could that person be to give consent? Would they have to be above the age of 16 but below 18? Could they be 12? Could they be eight? There does not seem to be any clarification elsewhere in the Bill or anywhere in the group of amendments.

Dawn Primarolo: The hon. Member for Boston and Skegness asked about consent. What I described as general consent is the position that all the consent works from for disclosure of information. The patient is able to put exceptions into that. If the hon. Gentleman recalls the exchange between myself and my right hon. Friend the Member for Coatbridge, Chryston and Bellshill in last Thursday’s sitting, my right hon. Friend said that he might be prepared to give consent for certain types of research, but that he would want to make exceptions in other areas. We were talking about cases in which the donor was deceased. However, that starts from a general consent in which patients have the option to put in exceptions.
Although we are talking about general consent, patients should have the ability to make explicit exceptions to their consent for the disclosure of that information if those exceptions are not overridden by any of the other exceptions. It would be much too complex to have the two consents working in different ways against different principles. I understand that matters would proceed in very much the same way, but it is crucial that the HFEA examines the issue very carefully when it takes on new considerations of consent. There will clearly be active discussion of those particular considerations with stakeholders and the individuals and organisations that have made representations on this part of the Bill. I hope that I have made clear how the process will operate.
The other question that the hon. Member for Boston and Skegness asked was how old a person needed to be for the purposes of consent. The system does not work on the basis of age, but on whether an individual has sufficient understanding of the implications of the decision. That is obviously a fine judgment that needs to be made. I do not think that we can take that away from clinicians because individuals vary in their understanding. That is why there is not a specific age. I do not think that that is at odds with how we test competency elsewhere. Everybody has to be satisfied that an individual understands the implications.
The hon. Member for Oxford, West and Abingdon asked me a question about Government amendment No. 45, and I think that I answered it. The amendment specifically ensures that the provisions cannot be used to require the HFEA to disclose identifying information about donors for which specific provision is made elsewhere in the 1990 Act and the Bill. The amendment is constraining in that it reflects the wish to keep the measure very tight to the specific purpose. It was a result of clarification and tidying up following the very extensive debate on these measures that was held in another place.
I think that I have answered all of the questions that I was asked. If I have not, the hon. Gentleman needs to say now. I hope that the Committee will support the Government amendments, which I shall move formally at the appropriate time.

Mark Simmonds: I am grateful to the Minister for that clarification. On the basis of her response both to my questions and to the amendments that I have tabled, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendments made: No. 45, in clause 25, page 26, leave out lines 22 to 41 and insert—
‘(g) the disclosure is made so that no individual can be identified from the information,
(h) the disclosure is of information other than identifying donor information and is made with the consent required by section 33AB,’.
No. 46, in clause 25, page 26, line 41, at end insert—
‘(ja) the disclosure—
(i) is made by a person who is satisfied that it is necessary to make the disclosure to avert an imminent danger to the health of an individual (“P”),
(ii) is of information falling within section 31(2)(a) which could be disclosed by virtue of paragraph (h) with P’s consent or could be disclosed to P by virtue of subsection (10), and
(iii) is made in circumstances where it is not reasonably practicable to obtain P’s consent,’.
No. 47, in clause 25, page 27, leave out lines 38 to 50.
No. 48, in clause 25, page 28, leave out lines 1 and 2.
No. 49, in clause 25, page 28, line 7, leave out from ‘of’ to ‘or’ in line 12 and insert ‘identifying donor information,’.
No. 50, in clause 25, page 28, leave out lines 18 to 30.
No. 51, in clause 25, page 28, line 36, leave out ‘treated together with another’ and insert
‘who is treated together with, or gives a notice under section 37 or 44 of the Human Fertilisation and Embryology Act 2008 in respect of, another’.
No. 52, in clause 25, page 28, leave out lines 39 and 40.
No. 53, in clause 25, page 28, line 45, at end insert—
‘( ) In this section “identifying donor information” means information enabling a person to be identified as a person whose gametes were used in accordance with consent given under paragraph 5 of Schedule 3 for the purposes of treatment services or non-medical fertility services in consequence of which an identifiable individual was, or may have been, born.’.
No. 54, in clause 25, page 28, line 45, at end insert—
‘33AB Consent required to authorise certain disclosures
(1) This section has effect for the purposes of section 33A(2)(h).
(2) Subject to subsection (5), the consent required by this section is the consent of each individual who can be identified from the information.
(3) Consent in respect of a person who has not attained the age of 18 years (“C”) may be given—
(a) by C, in a case where C is competent to deal with the issue of consent, or
(b) by a person having parental responsibility for C, in any other case.
(4) Consent to disclosure given at the request of another shall be disregarded unless, before it is given, the person requesting it takes reasonable steps to explain to the individual from whom it is requested the implications of compliance with the request.
(5) In the case of information which shows that any identifiable individual (“A”) was, or may have been, born in consequence of treatment services, the consent required by this section does not include A’s consent if the disclosure is necessarily incidental to the disclosure of information falling within section 31(2)(a).
(6) The reference in subsection (3) to parental responsibility is—
(a) in relation to England and Wales, to be read in accordance with the Children Act 1989;
(b) in relation to Northern Ireland, to be read in accordance with the Children (Northern Ireland) Order 1995;
(c) in relation to Scotland, to be read as a reference to parental responsibilities and parental rights within the meaning of the Children (Scotland) Act 1995.’.—[Dawn Primarolo.]

Clause 25, as amended, ordered to stand part of the Bill.

Clause 26

Mitochondrial donation

Question proposed, That the clause stand part of the Bill.

Mark Simmonds: There may be a logical reason for it, but why is such a clause placed at this part of the Bill and not sequential to clause 3, because that was when we discussed mitochondrial donors? It does not seem to fit here.
I want to ensure that I, as well as other members of the Committee, understand the clause correctly. It deals with proposed new sections 31ZA to 31ZE. Will the Minister confirm that that means that the offspring has the right to find out about the mitochondrial donor and the donor’s children? Does the mitochondrial donor have the right to find out about the ensuing offspring, despite the fact that only 0.5 per cent. of their genetic material is in the child and does not have any defining characteristics whatever?

Dawn Primarolo: I can answer the second question; I do not know about the first. The hon. Gentleman might recall that we had an extensive discussion on the right to know and information about mitochondrial donations. The hon. Member for Oxford, West and Abingdon asked whether there would really be a need for the mitochondrial donor to be identified. We agreed at the time that, because regulations are connected with such information, such issues were exactly the type that would need to be consulted on, and that the regulations would need to be seen in draft.

Mark Simmonds: I have a clear recollection of that discussion, but my reading of the Bill is that proposed sections 31ZA to 31ZE give the offspring the right to find out about the mitochondrial donor and the donor’s children. The Minister is suggesting that that is not the case and that, subject to consultation, such matters will be dealt with in subsequent regulations. I accept that I might have misinterpreted the Bill, but I should be grateful if she could clarify matters.

Dawn Primarolo: I can clarify that that is the case. The regulations deal with that entire part, so it will be possible to take it forward. The requirement is not linked.

Evan Harris: Proposed new section 35A(1) states that regulations
“may provide for any of the relevant provisions”,
and the hon. Gentleman has described some of the provisions. As I have said, I am dubious whether a system needs to be set up for a healthy child who has no relevant genetic parentage—in my opinion—to be invited to consult a register and so on. Arguably, it is part of the private medical history of the parent even though it impacts on the child, but children do not have the right to know that their mothers had tubal surgery, for example. Such matters will need to be debated before regulations emerge.

Dawn Primarolo: I absolutely agree. When the hon. Gentleman made that point, with justifications that he felt supported that view on access to information, he put it clearly. At the time I also said that in my view—this is certainly provided for as regards regulations—the issue is a matter for debate and consultation, which would need to take place before the regulations are drafted. There would then be consultation on the draft regulations before they went through the affirmative procedure in both Houses.
The measure appears where it does in the Bill because it contains regulation-making powers, and they tend to be placed at the back of an Act, in relation to the points that they connect to, so it is about drafting legislation. I say in all honesty to the hon. Member for Boston and Skegness that that is the advice from advisers, parliamentary counsel and all those who regularly write legislation. I tend to worry about the bigger issues of principle, rather than the consequential sequencing of the clauses. I hope he accepts that.

Question put and agreed to.

Clause 26 ordered to stand part of the Bill.

Clause 27

Fees

Mark Simmonds: I beg to move amendment No. 155, in clause 27, page 31, line 13, leave out ‘revocation or’.
This is a probing amendment to elicit from the Minister an explanation of why the authority has the power to charge for a revocation of a licence, and what happens in circumstances where the licensee who has had his or her licence revoked refuses to pay, or their business is wound up and no longer exists. Is it right that the licence is revoked at the discretion of the authority and that therefore the licensee is charged—the authority can both revoke the licence and make a charge—particularly since the Bill does not state that the charge may only cover costs and not generate revenue for the authority?

Dawn Primarolo: The hon. Gentleman raised points earlier about the responsible person if a licence were revoked or a request to revoke a licence were made by the clinic. He made specific reference to the provisions for patients who might already be having treatment, and to ensuring that the storage of embryos, material and information is done in the proper way. I made it clear to him that those matters were requirements of the licence. The payment of the fee is to ensure that those arrangements can be made, and it may be that it is transferred to another clinic for treatment, for instance, or for maintenance.
The circumstances for a clinic that was closing down and submitted that it wished to have its licence revoked would be rather different to cases where the HFEA was revoking a licence for its own reasons, but none the less, administrative expenses would occur both for the HFEA and for patients going to other areas. It is not about income generation for the HFEA. As was said in our earlier discussion about fees charged by the HFEA, it may charge a fee, but it does not have to do so. Specific provision is not made in the Bill for such charges, but it is envisaged that they would be covered, because there would be consequential expenses. I assure the hon. Gentleman that it is not about income generation for the authority. I hope that that covers his questions.

Mark Simmonds: I am grateful for the Minister’s clarification that total revocation of the licence and charges related to that are not temporarily—essentially—income generating. Has any thought been given to a charge that might have been made to a licence holder who has had the licence revoked and who refuses to pay? Would that bar, for example, somebody from getting a licence in the future?

Dawn Primarolo: That would clearly reflect on the responsible person, and whether they were responsible enough to have a future licence, bearing in mind how they discharged their responsibilities for a licence that they no longer have. Either they revoked it themselves by wishing to withdraw from the licence, or the HFEA revoked it because of breach of licence. It comes back to that debate about responsible people.

Mark Simmonds: I am grateful for that intervention, and I certainly do not wish to push amendment No. 155 to a vote. On that basis, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Mark Simmonds: I beg to move amendment No. 156, in clause 27, page 31, line 26, at end insert
‘set out in regulations laid in draft before and approved by a resolution of each House of Parliament.’.

Jimmy Hood: With this it will be convenient to discuss amendment No. 157, in clause 27, page 31, line 38, leave out ‘may’ and insert ‘must’.

Mark Simmonds: The amendments relate again to the fees that the HFEA can charge. I will detail what they would do, and then I want to talk a little more, if I may, Mr. Hood, and ask the Minister to provide information about the charging structure and the HFEA’s fees.
The Bill as drafted allows for the fees to be fixed by the authority with the approval of the Secretary of State and the Treasury. Amendment No. 156 would ensure that the fee is fixed in Parliament through regulations, which would go some way to ensuring that the fee is fair and proportionate and would not necessarily be passed on disproportionately to the patients by the clinics. The Minister will be aware of the enormous concern about that within both main political parties.
On amendment No. 157, the Bill as drafted says that any fee charged for the provision of information about genetic offspring, siblings or a potential partner, may have regard to the costs incurred, which clearly also implies that it may not have regard to the costs incurred. The amendment would change that “may” to “must”, which would therefore mean that fee charging must not be a revenue-raising exercise. I was grateful for the Minister’s confirmation that the fees charged for the revocation of a licence would not be a revenue-raising exercise and that the charges must be in direct proportion to the costs incurred in providing that information. The amendment would ensure that the fee charged is proportionate to the costs incurred in obtaining and providing that information.
With your permission, Mr. Hood, I would like to broaden the debate in terms of the charging structure of the HFEA, which relates to the amendments. I should like to elicit from the Minister some of the—

Jimmy Hood: Order. I must ask the hon. Gentleman not to go there. He may want to raise those points in our debate on clause stand part, but not in relation to the amendments.

Mark Simmonds: I am grateful for that advice, Mr. Hood, and I look forward to catching your eye then.

Robert Key: It is a pleasure to serve under your chairmanship, Mr. Hood. I support amendment No. 156, and if this Bill is sublime, then I should like to introduce the Committee to the ridiculous. First, I want to consider the principle behind the charging regime.
Several years ago, on behalf of a constituent, I challenged the HFEA on the fees that it was charging for in vitro fertilisation treatment, and I was told that the Treasury insists on the fees being charged. Indeed, clause 27 inserts proposed new section 35B(2), which, as my hon. Friend said, gives the Treasury the final word on these fees.
The Treasury does not object to NHS dentists charging for certain procedures and contraptions, and it seems that it does not object to NHS eye tests that result in contact lenses being purchased by patients. On the other hand, the NHS does not allow people to buy drugs that have not been approved for NHS use by the National Institute for Health and Clinical Excellence. It says—entirely out of spite, it seems—that the whole course of treatment might be jeopardised if additional drugs are purchased. The Department of Health therefore seems to be in a complete muddle about charging structures.
On my second point, proposed new section 35B(5) says:
“the Authority may have regard to the costs incurred”.
It is often said that this is all about legal fees, which might be huge. However, if legal fees are incurred in the health service—for example because an orthopaedic procedure goes wrong and results in litigation—the hospital or department concerned does not have to pay the legal costs involved in meeting that challenge. How, therefore, can it be justified to reflect legal costs in the fees charged to clients and patients under the HFEA regime?
Proposed new section 35B(6) says that the HFEA
“may fix different fees for different circumstances.”
Will the Minister clarify that? Does that mean that the authority can charge different fees for the same HFEA functions under different circumstances? If so, who will make the decision? What will the criteria be? Will the Minister give us examples of what is meant by new section 35B(6)?
How are our constituents affected by this regime? The cost of each IVF cycle to our constituents is about £3,500 for fresh gametes and £1,000 for frozen gametes.

Jimmy Hood: Order. I think that the hon. Gentleman is going a wee bit away from the amendment. Again, the issue could be raised in the clause stand part debate, not on this group of amendments.

Robert Key: I obviously have to accept your ruling, Mr. Hood, but I am talking very specifically to amendment No. 156. May I please proceed?

Jimmy Hood: Order. I tell the hon. Gentleman that clause 6 is not being amended, but he is speaking to it as if it is.

Robert Key: Mr. Hood, I am talking about amendment No. 156 to clause 27, which was moved by my hon. Friend the Member for Boston and Skegness.

Jimmy Hood: Order. My guidance to the hon. Gentleman is to look to the clause stand part debate and to speak specifically to the amendment. That is in line with my earlier advice to the hon. Member for Boston and Skegness.

Robert Key: Of course, I accept your ruling, Mr. Hood. If I may, I will speak to clause 27, page 31, line 26—to amendment No. 156.
On the fees that are charged for cycles, NHS trusts will not pay for frozen cycles, and I wonder who made that ruling. An application for a separate licence must be made for each and every cycle, and that must be granted by the HFEA. The authority charges £104.50 per licence. That means that the Salisbury fertility clinic, which treats about 200 patients a year with fresh or frozen cycles, pays about £200,000 a year in fees. There are more than 100 IVF clinics in the UK, so our constituents pay about £2 million a year.

Mark Simmonds: It might help my hon. Friend if I give him the exact figures. In the 2006-07 financial year, HFEA income was £6.7 million, of which grant aid—I assume that it came from the Department of Health—was £1.95 million. That means that the authority got £4.8 million in fee income from our constituents.

Robert Key: That is absolutely right. The IVF cycles paid for by our constituents represent a significant proportion of that income.
The proportion of private and NHS patients being charged is about half and half. In half the cases, therefore, the HFEA fee is paid by the patients, while in the other half, it is paid by the primary care trusts. However, the primary care trusts are simply transferring money from one part of the NHS to the other, with all the concomitant bureaucracy involved in the procedure. That, in itself, must cost a substantial amount.
There is another unfairness for our constituents in the charging structure. If, in an IVF cycle, there were some spare gametes for a patient, some of them would routinely be frozen in case they were needed in the event of failure. If the fresh cycle fails, believe it or not a new licence costing another £104.50 has to be applied for and granted—for the same gametes. The patient is therefore paying twice yet the clinic incurs no extra cost, apart from the cost of the storage of spare gametes. How can the whole bureaucracy and fee structure be justified for what is now a routine procedure?

Mark Simmonds: Is my hon. Friend aware that financial implications arise from the Bill? He has suggested that the expectations of increased expenditure by the HFEA will be met not by additional resources from the Department of Health, but only by additional fees being charged.

Robert Key: I detect the dead hand of the Treasury intruding once again into the personal lives of our constituents. I entirely support my hon. Friend’s amendment. On behalf of our constituents, it should be Parliament, not the Treasury, that decides whether the charging regime is justified.

Dawn Primarolo: I wish to explain what actually happens and why, rather than there being a dastardly plot set up by the Treasury.

Hon. Members: It is quite possible!

Jimmy Hood: Order.

Dawn Primarolo: It is a little strange that Conservative Members wanted the regulation that was accepted when the 1990 legislation went through under their Government, whereby there should be a fee structure to recoup the costs of the regulation, yet they now consider that that principle should be broken in respect of what the fees are charged for and how they are arrived at.
Amendment No. 156 would provide for the fees to be set out in regulations to be approved by both Houses. The HFEA undertakes consultation on its fee scheme and levels involving the public and stakeholders. That is similar to provisions under the 1990 Act. The Bill provides that the HFEA can set its fees in accordance with the scheme approved by the Secretary of State and the Treasury, and I see no reason to change that. At present, the HFEA makes a recommendation, having discussed with stakeholders what they believe the fee levels should be. A review is undertaken every two years, and it is not the case that fees always increase.
This is not about the Treasury saying what will be charged, but the HFEA asking for endorsement. That ties in with the fact that the HFEA is a quasi-independent body. We made the important decision recommended by the Warnock report so that matters relating to the function of the authority, including how it carries out its functions in respect of fees, are properly the business of the authority to determine and justify. That was where the authority was in 1990. That was recommended in the discussions on the independence of the HFEA in discharging its regulatory functions as determined by Parliament, and the fees are about recouping its costs.

Robert Key: Will the Minister give way?

Dawn Primarolo: I am happy to give way. I will answer in detail the points that the hon. Gentleman has already made. I accept that he has changed his mind since 1990, but the Government have not.

Robert Key: Eighteen years ago, when the Minister and I were fresh young things on the Standing Committee that considered the 1990 Bill, the HFEA was a new institution and nobody knew how much it would cost to run. The procedures for IVF were novel and nobody knew how they would be taken up or what that would cost the NHS. Caution, therefore, was entirely sensible. The point that I have already made, which the Minister has failed to acknowledge, is that these are now routine procedures and routine parts of NHS performance, and that we need to change our minds. Parliament needs to change its mind. We no longer insist on people walking in front of cars with red flags, and we should not insist on this charging regime.

Jimmy Hood: Order. That was a rather long intervention.

Dawn Primarolo: I understand the hon. Gentleman’s point. We continue to regulate the system. Some argue that there should be no regulation on IVF because it is so mainstream. They say that we should not have the regulation that is provided in the Bill and that the matter should be removed entirely from the auspices of the HFEA. However, that is not the view endorsed by Parliament, nor is it the view of the Government. The HFEA’s independence would be eroded and undermined by the amendment, yet it has to have independence. The other question is where we would draw the line on the HFEA’s independence. Would we allow it to determine its own procedures for using its regulation powers, regulating according to the wishes of Parliament, and the costs for that? It may also be considered that removing from the authority the responsibility for setting such procedures will work against better regulation. We need to ensure that the authority has an incentive to reduce the regulatory burden and improve its procedures, that it regulates according to the wishes of Parliament and that it does so in dialogue with its stakeholders, and takes into consideration what they think. The first implication of amendment No. 156 is that it should not be the function of the HFEA to set its own fees. That is something with which the Government and I do not agree. It is appropriate that the HFEA seeks to recoup the cost of regulating clinics.
Other costs that the HFEA might incur, such as legal fees, are met by the Department as part of the HFEA’s grant. Members of this Committee and of the House expect the Government to be concerned to ensure that the HFEA is fulfilling its functions in an efficient and cost-effective way. That would always be part of the discussions about the rest of the running, not the regulation of the licences.
I hear what the hon. Member for Salisbury says about the level of fees, but I think that that is a separate issue. It is entirely appropriate that the HFEA intends to review its fee structure as part of the major project to consider how it operates and how it is undertaking its role. It must take into consideration the implications of the Bill, when it is approved by Parliament, and reflect on the points made by the hon. Member for Salisbury—whether it is timely to revisit when fees are applied, at what level and for what purpose.
I remind the Committee that the fees are paid by clinics and research centres towards the HFEA’s operating costs, including the continuing work to improve and strengthen regulation. The fees cover, for example, the cost of licensing and inspecting clinics to ensure that they are complying with the HFEA code. The authority reviews its fees annually and makes a recommendation to the Secretary of State, who agrees them. They are approved by the Treasury as well. As I said, they are not increased every year.
The current fees were referred to by the hon. Member for Salisbury, so I do not need to touch on them. The fees paid for costs depend on the type of treatment carried out or the complexity of the research, but, as I said, the HFEA is reviewing its fee structure. It is important that there is transparency on the level of the fees, why they are set at those levels, the costs that they are intended to cover, and that everyone understands that clearly. I do not accept that amendment No. 156 would improve how fees are set or take us any further forward. In fact, it would be in danger of questioning the independence of the HFEA.
Amendment No. 157 relates to the authority’s ability to charge a fee to people making an application for information from the register or for providing the information. Clause 27 is intended to enable the HFEA only to cover the costs of doing so and, as I have said repeatedly when the question of HFEA fees has been raised in Committee, it is not about income generation. The effect of amendment No. 157 would be that the authority “must”, rather than “may”, have regard to the costs incurred by it when dealing with an application or the provision of information about genetic parentage. On a straightforward technical point, the use of “may” is common in legal drafting and is appropriate in cases in which there is no obligation. That is clearly the point that we are trying to get across. The HFEA does not necessarily have to charge a fee for requests for such information as are proposed, and therefore “may” is entirely appropriate in such circumstances.
While I understand the points made by the hon. Members for Boston and Skegness and for Salisbury, and the force with they are making them, I hope that they agree that a more sensible way to proceed would be to allow the HFEA to continue to be accountable, to review its fees, to be in discussion with its stakeholders and then to make recommendations to the Secretary of State and the Treasury for approval, once those increases, decreases or no increase are decided. If the authority does that annually, it is entirely appropriate for that to continue. If the hon. Member for Boston and Skegness feels that he needs to press his amendment to a Division on that principle, I will ask my hon. Friends to resist it.

Evan Harris: Since there may well be a vote on the amendment, I ought to say one or two paragraphs on it. The Minister is absolutely right that if we believe that IVF has to be regulated, there must be fees to pay for it—that is if we agree that the regulator should be funded at least partly by the people whom it regulates, which is a common model.
I have long argued a point that I think the Select Committee report of 2005 made: now that we are 15 years on from the halcyon days of the fresh youth described by the hon. Member for Salisbury—perhaps others might argue that he and the Minister are still both fresh young things—IVF is just as routine, after the initial concerns about safety, as some unlicensed treatments involving drugs and surgery. Although there is an ongoing requirement of registration for the purposes of donor information and so on, I hope that it will be accepted that there is an argument for deregulation. That does not mean that there does not need to be quality assurance by the Healthcare Commission, involvement by the General Medical Council, or even close scrutiny of claimed success rates, because IVF is relevant to a particularly desperate population. However, should that mean licensing every routine IVF cycle? No, although I would still argue that some of the newer approaches should be licensed and that there should be no diminution of the regulation of research.

Dawn Primarolo: The hon. Gentleman is making a respectable case for having no regulation. I do not happen to agree with him, but surely the hon. Members for Boston and Skegness and for Salisbury need to address the point that the principle of regulation is that its costs are recouped from those who are regulated. That has been an absolute principle of all the relevant legislation since 1990. Not liking the fees is one thing, but a case has not been made for why we should deviate from the principle of regulation.

Evan Harris: I made that point at the beginning. If we believe that IVF should be regulated, we must have a way of paying for it. I am making the point that it should be deregulated. However, given that there is regulation, and that the Select Committee did not win the argument on that point, the Government’s structure is a reasonable approach. That is the only reason why I do not plan to support the amendment. A better approach would be to deregulate. Although there will, of course, be sensitive issues and a need for special provisions when we discuss the next Bill, I hope that this medical treatment, which is now routine and, as far as we know, safe—no less safe than many other medical treatments—will be deregulated.

Mark Simmonds: I am delighted that the amendments have stimulated such a detailed and comprehensive discussion. As my hon. Friend the Member for Salisbury said, there is concern about the issue and the possibility of fees being charged that will impinge on all our constituents.
The point of amendment No. 156 is not to remove the independence of the HFEA but to ensure that there is sufficient scrutiny by those who represent constituents, on whom the level of fees will have an impact. The Minister is not correct to say—I may have misheard her—that all HFEA income is recouped through recharging. It is not. There is a grant aid system, which pays some of the cost. There is no doubt that the Bill has the potential to increase the HFEA’s level of activity and its size. My understanding is that there is no proposal to increase the grant aid from the Department of Health, so the additional income will come from the charging of additional fees.
Of course, I acknowledge that while the Minister is in situ, she will consult the Secretary of State and the Treasury and will not allow the fees to be a revenue-generating exercise, but that may not always be the case. If I were a Minister rather than a shadow Minister, I would ensure that they only covered the costs rather than raised revenue. We must ensure that that happens as part of the Bill, because the 1990 Act, which we are amending, has been in place for 18 years, and we hope that this Bill will be as well. I do not think that the HFEA would have a rigorous and detailed charging regime imposed on it by Parliament, but is right that the HFEA should come to Parliament to justify its fees and the impact that they would have.
If I withdrew the amendment, it would be with some reluctance, so I am not going to do so.

Question put, That the amendment be made:—

The Committee divided: Ayes 5, Noes 11.

Question accordingly negatived.

Question proposed, That the clause stand part of the Bill.

Mark Simmonds: Just for clarification, do I need to withdraw amendment No. 157 formally?

Jimmy Hood: It is deemed as having been withdrawn.

Mark Simmonds: I do not wish to detain the Committee by getting the Minister to tell us verbally what the answers are, but it would help if she could furnish the Committee with the relevant information. Clearly, as we have said, there is concern about the HFEA charging regime and how it might grow. I imagine that people in the HFEA have done projections for the next three years about how they imagine the fee income will grow, how they imagine their expenditure and cost base will expand, and what those additional costs and expenditures will be spent on. Will the Minister put that information in the public domain, because financial implications clearly arise from the changes proposed in the Bill—particularly if birth registration is changed. As the HFEA grows in its remit, the expectation is that increasing expenditure will be met by fee income. It would be helpful if the Minister could write a letter to members of the Committee or place something in the House of Commons Library on that matter. Doing so would ensure that both the Committee and the wider public have detailed financial information about the proposals on the financing of the HFEA.

Dawn Primarolo: I am not quite sure how I can help the hon. Gentleman any further than I already have. The agreements in terms of finances for the HFEA are subject to public scrutiny through the information that it provides. I have said that the HFEA will consult on the level of fees. In addition, the Department would expect the enactment of the Bill to result in the HFEA reflecting on its future requirements and submitting a business case to us on the additional grant aid it might need to deal with the Bill’s implications. A letter would say no more than that until the Government are in a position to say more publicly, because all these matters are about to be consulted on. The fees and the future liabilities will need to be considered in the context of the Bill, which is not yet an Act.
I hear what the hon. Gentleman is saying and I will keep him informed of developments once the Bill is enacted. Until then, I am not able to say a great deal more because the HFEA will have to reflect on the matter.

Question put and agreed to.

Clause 27 ordered to stand part of the Bill.

Clause 28

Inspection, entry, search and seizure

Question proposed, That the clause stand part of the Bill.

Mark Simmonds: Will the Minister help the Committee by saying how many times the powers of entry, search and seizure under warrant have been used between 1990 and the present time, and how many times they have resulted in prosecutions, if any? I think that the powers were granted under section 38 of the 1990 Act.
My understanding is that the clause allows for members of the authority to be in possession of embryos, gametes or human admixed embryos in the course of their employment. I just wondered what that means. Does it mean that members of the authority are allowed to seize embryos, gametes or human admixed embryos from licensed premises as part of their employment or that they can hold them separately in a different function? Will the Minister also confirm that this is only the case if the cells have been seized?
It would also be helpful if the Minister explained, in the context of the clause, the procedure for informing donors and owners of these embryos and gametes that they have been seized, and if she described the methods and places for their storage to prevent degeneration and loss. As well as seizing property, gametes and embryos from licensed premises, can the authority take control of a facility where it believes somebody has broken the clauses of the licence?

Evan Harris: I want to raise the unfortunate recent case of Dr. Taranissi’s clinic and the HFEA. My understanding of the clause and new schedule 3B is that this is a significant move. It must be done carefully and not carelessly. In the Taranissi case, the appropriate steps were not taken when a sudden inspection entry involving search and seizure took place. It was unfortunate that it happened with television cameras from “Panorama” present down the street.
I am sure the Minister would agree that the clause covers a serious business and that inspections should not be carried out for the implied benefit of the media. The HFEA, which gets a lot of unfair criticism, should not be using its powers to have a public relations exercise to show “Panorama”, the BBC or any other broadcaster or media that it is being tough. The powers that it has speak for themselves. Implemented responsibly, they can do the job. I hope that the Committee agrees that there should be no repetition of that media circus in these matters. The HFEA was in court and had to settle a significant sum of money at the public expense for using the powers inappropriately.

Dawn Primarolo: Two sets of questions have been raised. The hon. Gentleman raised the Taranissi case and whether the current powers are being used correctly. The hon. Member for Boston and Skegness asked for clarification.
It is clearly not appropriate for me to comment on the case to which the hon. Member for Oxford, West and Abingdon referred. He speculates—I put it delicately—as have others, as to whether the powers of the HFEA, which I think he accepts are appropriate in the circumstances, were used appropriately in that case. That continues to be debated. The hon. Gentleman does not raise questions about the inappropriateness of the 1990 Act, as amended by this Bill, but he does raise issues that the HFEA needs to reflect on. The HFEA is following these proceedings carefully, and I am sure that it will note the points raised.
The requirement to inspect licensed premises at least every two years was set out in regulations under a European Union directive. Previously, the 1990 Act had provided for inspection every year, although that requirement could be waived by a licence committee, if the authority considered an inspection in that year to be unnecessary. All this clause does is bring those requirements for inspection, entry, search and seizure in line with the changes that the Bill makes regarding electronic records. It means that there is a regulating power to ensure that the legislation is future-proof. That power will enable the Secretary of State to specify what information should be contained in the appropriate statement given to a person on the premises during the execution of a warrant. The requirements and what actually happens are not being varied from the principle.
The hon. Member for Boston and Skegness asked for details of specific seizures or cases—how many times and where. I cannot remember what time period he asked about. I am afraid that I will have to write to the Committee with those statistics, as I do not have them to hand. He then asked what the possession of gametes means. It means that in the course of duty, HFEA staff could seize embryos but would not be exempt from needing a licence in other circumstances. As I tried to explain, we are bringing the new provisions in line with the existing framework.
The hon. Member for Oxford, West and Abingdon raised questions on a particular case, and while it is entirely inappropriate for me to comment on it, I will perhaps see, having consulted the HFEA, whether I can put in writing to the Committee something helpful with regard to the interpretation of its powers.

Question put and agreed to.

Clause 28 ordered to stand part of the Bill.

Schedule 5

Schedule inserted in the 1990 Act as Schedule 3B

Question proposed, That the schedule be the Fifth schedule to the Bill.

Mark Simmonds: I have a couple of questions about the schedule, which provides detail on inspection, entry, search and seizure. First, are the premises searched and the dates on which they are searched publicised? Is it public information? Is compensation paid if search and seizure has taken place but there was no prosecution or variation in licence? That is one reason why I asked a little earlier—a question that the Minister could not today answer—how many seizures have taken place since the 1990 Act came into force.
Secondly, how much notice, if any, needs to be given for entry under the schedule, or is it merely random, with those doing the inspection turning up as and when they see fit? Indeed, it may be sensible for someone to be there to demonstrate that there is nothing wrong or untoward with the licence.
If my understanding is correct, provisions in earlier parts of the Bill allow third parties to be contracted by the HFEA to enter and inspect premises under the schedule. Will permission need to be granted by the authority for those arm’s length bodies to undertake that work in individual cases, or will it be a block contract, with the bodies inspecting on behalf of the HFEA acting on their own discretion?
The Minister answered my question about two years, but I want clarification of a further matter in relation to paragraph 7(1)(a) to proposed schedule 3B about seizure in the course of inspection. I am puzzled as to why the HFEA or a body acting on its behalf would want seize anything when granting a licence or varying a licence at the request of a person who already has one. I understand why seizure might be applicable in revocation or suspension cases, particularly if it is to be used for evidence for the proceedings detailed in paragraph 7(2) to proposed schedule 3B.

Dawn Primarolo: We covered the question of qualified inspectors not directly employed by the HFEA in a previous debate, and what they would inspect—the laboratories and equipment, rather than some of the other issues. It would be necessary for that person to be a qualified inspector.
As for periods of inspection and notice of inspection, I do not have information to hand on that; it operates at present, and as far as I know we have not had any problems. However, if the evidence justifies it, we need to allow for spot inspections. I shall need to include that in the letter that I have written to the hon. Gentleman; it will be a subset. He asked whether details of seizures will be made public—perhaps on the HFEA website—and if there is no such obligation, why not. There may be some caveats, so I shall certainly write to him on that.
The last point raised by the hon. Gentleman was about compensation when a search has taken place. No provision has been made for compensation. The whole point is that those making inspections and seizures under the 1990 Act should act reasonably. That means within a certain time, and it also requires a reason for the inspection. All that would have to be demonstrated, and I will put that into the letter too.
This regime has worked well. The hon. Gentleman will need to be satisfied when I give him the details of how many revocations there have been and how many inspections have resulted in revocation, but I say to him that the whole point of the regime is that it does not need to be used often and in the period since 1990—apart from the required inspections—those spot inspections or seizures have not been used often. I hope that I will be able to reassure him and other members of the Committee on that in writing.

Mark Simmonds: I am grateful to the Minister for that answer. Perhaps she could add to that list of paragraphs in the letter that she is going to write a brief explanation of the last point that I made regarding paragraph 7(1)(a). In other words, why is it necessary to have as grounds for the seizure the purposes of the authority’s functions relating to the granting or variation of a licence, which would include the variation of a licence at the behest of a licensee? I cannot think of any situation where anything would be seized in those circumstances.

Dawn Primarolo: I am happy to confirm that I will address that point. I apologise for missing it.

Question put and agreed to.

Schedule 5 agreed to.

Clause 29

Offences under the 1990 Act

Evan Harris: I beg to move amendment No. 173, in clause 29, page 33, line 20, at end insert—
‘(10B) It is a defence for a person (“the defendant”) charged with an offence of doing anything which, under section 3(1) or (1A), 4(1)(a) or 4A(2), cannot be done other than in pursuance of a licence, to prove that at the material time the defendant believed on reasonable grounds that what they did was not something to which the Act applied.’.
This amendment, which deals with a potential new defence under the clause, is a probing one that tries to clarify what will happen in the new situation. The problem is caused by the new definition of an embryo, which clearly has been decided already during the procedure and has been debated in this Committee. It is now accepted that that issue will not be re-opened, and that an embryo is as defined at the beginning of the Bill, in clause 1. It must be recognised that that is a new definition that, from enactment, will capture issues that are not currently captured, and which are therefore not subject to regulation and do not require licences. As a consequence, the criminal law will be brought into new areas.
That creates a new problem: due to the nature of science, it is not entirely clear when something might be defined as an embryo under the Bill. We touched on that problem when we debated the clause in question, and following an exchange that I had with the Minister, it was covered in a letter that was sent to you, Mr. Hood, your co-Chairman and members of the Committee. That letter makes it clear that there is, as far as researchers are concerned, a particular problem.
I shall set out briefly the problem that might require defence. I draw attention to the fact that it was first raised in the House of Lords, following representations made in a briefing to all relevant peers by the Academy of Medical Sciences, the Medical Research Council, the Law Society, the Wellcome Trust and the Association of Medical Research Charities. That briefing set out the problem in relation to the amendment, which I have re-tabled to try to take the debate on. The briefing states:
“Embryos are broadly defined under the Bill to include ‘an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo’. Gametes are also broadly defined to include germ line cells at any stage of maturity. Our understanding”—
that is, the scientists’ or science’s understanding—
“of the processes by which eggs develop into embryos and cells develop into germ line cells is incomplete. It is therefore possible that a researcher could store or carry out research on cells that are not currently known to be or destined to become germ line cells, or could carry out research on eggs that are (unknown to current science) capable of resulting in an embryo.”
The argument—the thrust of the amendment—is that it should be a defence for a researcher if they can prove that they reasonably believed that what they stored or were creating was not a gamete, embryo or interspecies embryo as defined in the Bill. Of course, the researcher would have to cease their activity, seek a licence or destroy the material as soon as it became reasonably clear that that was necessary.
There is an analogous defence in the Human Tissue Act 2004, which the Minister in the other place mentioned in the debate on the amendment. She said:
“The noble Lord, Lord Patel, said that the Human Tissue Act had a similar defence and asked why it was not appropriate for the Human Fertilisation and Embryology Bill also to have a similar defence. Although this is a defence under the Human Tissue Act, the activities that require a licence under the Human Fertilisation and Embryology Act 1990 relate to the handling of human embryos and gametes, and the sensitivity of these activities means that it is imperative that scientists are aware of whether their activities require a licence under the Act.”—[Official Report, House of Lords, 28 January 2008; Vol. 698, c. 469.]
That is true, but I do not believe that it answers my point. We are not talking about a defence based on ignorance of the law, and it is unfortunate that that did not come across clearly in the Lords debate. Unquestionably, researchers in the field know what the law is and that an embryo that is created—that outcome is likely or at least possible—predictably and reasonably comes under the Act. This is about the uncertainty of the law, not the science.
Clearly, such a defence was felt necessary for inclusion in the 2004 Act, which also dealt with sensitive matters. It therefore seems reasonable to include a similar, if narrower, defence in the Bill if we accept that there is a problem.
I should set out the circumstances in which such a defence could be required. Again, I am grateful to the Newcastle scientists for meeting me last night to provide me with more specific information. They said that several centres in the UK—the problem is not rare—are carrying out in vitro research on human eggs with the approval of a research ethics committee but not under an HFE licence, which is unnecessary because regulations under the HFEA exempt such research unless the eggs are fertilised or stimulated specifically to develop into an embryo. Lord Patel pointed that out in the Lords debate, and Mary Herbert, who is an expert in meiosis at the North East England Stem Cell Institute, has confirmed that although it is rare, the division of an egg cannot be ruled out because it may occur spontaneously and unexpectedly. There is no intention to create an embryo, but it is possible that any cultured egg may divide parthenogenetically; very occasionally—this is the point—the cell may continue to divide to a two-cell stage with a full set of chromosomes.
It is the view of those scientists and the Government that such an entity would be covered by the definition in clause 1. Therefore, an offence would in theory have been committed if such a thing occurs in an unlicensed laboratory. Will all research on eggs in vitro require a licence to avoid the problem? Are we unravelling the whole point of the regulations made under the 1990 Act shortly after it was passed that allowed gamete research to continue without a licence, as it does?
It is important to give one example of the work specifically concerning the investigation of the meiosis process, because it is ongoing. Meiosis is the division of chromosomes in the egg immediately before fertilisation, so that the number of chromosomes is reduced by half. Errors occurring during meiosis result in miscarriage and cause congenital abnormalities such as Down’s syndrome. The studies involve measuring proteins and other molecular signals within an egg as it undergoes meiosis. Research on how to store the eggs of young women to preserve their fertility before chemotherapy is another example.
In our exchange, which I shall not repeat, the Minister said that either embryos should be licensed or that the eggs that this might happen to should be destroyed, but her letter was clear. It is important that we recognise what it said. The Government’s letter to the Committee said that
“eggs can spontaneously activate and begin to divide without having been fertilised...It is highly unlikely that a human parthenote could implant and/or develop into a baby. However they do divide for several days in vitro allowing some research to be carried out on them.”
That would be research under a licence, because it would involve a parthenogenetic embryo. However:
“As well as occurring spontaneously, it is possible to stimulate parthenogenesis by exposing eggs to a specific chemical or by stimulating them with an electric shock.”
Again, that would require a licence under the Bill, which is fair enough, because one anticipates that that sort of thing will continue. The letter said that such embryos would be covered by the definition, and went on to say:
“As far as we understand, there are very few research projects involving human eggs which do not involve fertilisation of the eggs. The majority of research on eggs would involve creating an embryo, and therefore would require a license from the HFEA. However, we accept that where there was non-licensed research on eggs being carried out, there is a possibility that an egg may spontaneously begin to divide.
The Human Fertilisation and Embryology Act 1990 states that you cannot bring about the creation of an embryo in vitro without a license from the HFEA. Therefore, if a researcher were concerned that this might not be the case, they would need to obtain a license. The Bill does not change this position.”
I do not seek to argue with the letter; I am just setting it out to save time. The Bill changes the position. There was some doubt before, but now it is clear that spontaneous parthenogenesis, because it involves the creation of an embryo, albeit not deliberately, would require a licence. Is it the Department’s advice and the HFEA’s likely advice that anyone culturing eggs in vitro, even if there is no intention of stimulating them or creating embryos, will require a licence?
If that is the case, certainty is needed about it, or researchers may believe that even if it is not their intention, the research ethics committee does not feel that it is a possibility and they do not publish anything about parthenogenetic embryos, they may still be liable for a criminal offence. Although they may be able to “not have a problem”, as it were, now that the matter has been raised in the House of Lords and here, it is important to be absolutely clear for those researchers and to realise that there will be more research licences—and, pursuant to previous debates, more income for the HFEA—and an increase in regulation. I look forward to the Minister’s response.

Dawn Primarolo: I find it somewhat difficult to accept that although the very best scientists in the world, at the forefront of this science, know exactly what to do in order to progress that science, the hon. Gentleman seeks none the less to move an amendment to give them the defence that they did not know that they were doing something that the legislation applied to. We need to be very clear, and being very clear about what the offence is means that the scientists concerned must know the exact parameters within which they are working. There should not be an ambiguous judgment to be made about what a particular scientist may or may not have known at the point when they breached the legislation. There is no defence in the 1990 Act—

It being One o’clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.

Adjourned till this day at Four o’clock.